Gain an overview to align your company with the new requirements of the MDR
The new regulation on medical products, the Medical Device Regulation (MDR) 2017/745 (MDR), which replaces previous guidelines Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) 90/385/EEC, has entered into force as from 2017. All manufacturers of Class I to III medical products must familiarize themselves with the new requirements as soon as possible. The regulation has far-reaching implications and affects all classes of medical products. For the first time, products that are not medical products as such are regulated by the Medical Device Regulation (MDR).
Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. The European approval process is uniformly regulated and entails significant changes in terms of organization goals. The new scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes. In our one-day seminar, you will gain a compact overview to align your company with the new requirements of the Medical Device Regulation (MDR).
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Bosnia and Herzegovina